[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Notices]
[Pages 63732-63733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25452]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-306F]


Final Revised Assessment of Annual Needs for the List I Chemicals 
Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of Final Assessment of Annual Needs for 2008.

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SUMMARY: This notice establishes the Final Revised 2008 Assessment of 
Annual Needs for certain List I chemicals in accordance with the Combat 
Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.

DATES: Effective Date: October 27, 2008.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug & Chemical Evaluation Section, Drug Enforcement Administration 
(DEA), Springfield, Virginia 22152, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine 
Epidemic Act of 2005 (Title VII of Pub. L. 109-177) (CMEA) amended 
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by 
adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing 
language to read as follows: ``The Attorney General shall determine the 
total quantity and establish production quotas for each basic class of 
controlled substance in schedules I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine to be manufactured each 
calendar year to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks.'' Further, 715 of CMEA amended21 U.S.C. 952 ``Importation of 
controlled substances'' by adding the same List I chemicals to the 
existing language in paragraph (a), and by adding a new paragraph (d) 
to read as follows:

    (a) Controlled substances in schedule I or II and narcotic drugs 
in schedule III, IV, or V; exceptions:
    It shall be unlawful to import into the customs territory of the 
United States from any place outside thereof (but within the United 
States), or to import into the United States from any place outside 
thereof, any controlled substance in schedule I or II of subchapter 
I of this chapter, or any narcotic drug in schedule III, IV, or V of 
subchapter I of this chapter, or ephedrine, pseudoephedrine, and 
phenylpropanolamine, except that--
    (1) such amounts of crude opium, poppy straw, concentrate of 
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and 
phenylpropanolamine, as the Attorney General finds to be necessary 
to provide for medical, scientific, or other legitimate purposes, 
and * * *
    (d)(1) With respect to a registrant under section 958 who is 
authorized under subsection (a)(1) to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, at any time during the year 
the registrant may apply for an increase in the amount of such 
chemical that the registrant is authorized to import, and the 
Attorney General may approve the application if the Attorney General 
determines that the approval is necessary to provide for medical, 
scientific, or other legitimate purposes regarding the chemical.


    Editor's Note: This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 952(a) and (d)(1).

    The 2008 Assessment of Annual Needs represents those quantities of 
ephedrine, pseudoephedrine, and phenylpropanolamine which may be 
manufactured domestically and/or imported into the United States in 
2008 to provide adequate supplies of each chemical for: the estimated 
medical, scientific, research, and industrial needs of the United 
States; lawful export requirements; and the establishment and 
maintenance of reserve stocks.
    On June 23, 2008, a notice entitled, ``Proposed Revised Assessment 
of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, 
and Phenylpropanolamine for 2008'' was published in the Federal 
Register (73 FR 35410). This notice proposed the revised 2008 
Assessment of Annual Needs for ephedrine (for sale), ephedrine (for 
conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale) 
and phenylpropanolamine (for conversion). All interested persons were 
invited to comment on or object to the proposed assessments on or 
before July 23, 2008.
    DEA did not receive any comments or objections to the proposed 
revised Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2008. Therefore, under the 
authority vested in the Attorney General by Section 306 of the CSA (21 
U.S.C. 826), and delegated to the Administrator of the DEA by 28

[[Page 63733]]

CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 
CFR 0.104, the Deputy Administrator hereby orders that the Revised 2008 
Assessment of Annual Needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in kilograms of anhydrous acid or base, 
be established as follows:

------------------------------------------------------------------------
                                                              Final 2008
                                                              assessment
                      List I chemical                         of annual
                                                              needs (kg)
------------------------------------------------------------------------
Ephedrine (for sale).......................................       11,500
Ephedrine (for conversion).................................      128,760
Pseudoephedrine (for sale).................................      511,100
Phenylpropanolamine (for sale).............................        5,545
Phenylpropanolamine (for conversion).......................       85,470
------------------------------------------------------------------------

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this action will not 
have a significant economic impact upon small entities whose interests 
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the assessment of annual needs for ephedrine, 
pseudoephedrine and phenylpropanolamine is mandated by law. The 
assessments are necessary to provide for the estimated medical, 
scientific, research and industrial needs of the United States, for 
lawful export requirements, and the establishment and maintenance of 
reserve stocks. Accordingly, the Deputy Administrator has determined 
that this action does not require a regulatory flexibility analysis.

Executive Order 12866

    The Office of Management and Budget has determined that notices of 
assessment of annual needs are not subject to centralized review under 
Executive Order 12866.

Executive Order 13132

    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.

Executive Order 12988

    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

Unfunded Mandates Reform Act of 1995

    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Congressional Review Act

    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: October 7, 2008.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E8-25452 Filed 10-24-08; 8:45 am]
BILLING CODE 4410-09-P